WallFlex™ M00547540

GUDID 00191506044527

Stent System

BOSTON SCIENTIFIC CORPORATION

Polymer-metal biliary stent, non-bioabsorbable
Primary Device ID00191506044527
NIH Device Record Key8d8c6b59-fa1d-4306-88d2-07190c83e0ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameWallFlex™
Version Model NumberM00547540
Catalog NumberM00547540
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter
Stent Length60 Millimeter
Stent Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506044527 [Primary]

FDA Product Code

FGEStents, drains and dilators for the biliary ducts

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

On-Brand Devices [WallFlex™]

00191506044527Stent System
00191506044510Stent System
00191506044503Stent System
00191506044497Stent System
00191506044480Stent System
00191506044473Stent System
00191506044466Stent System

Trademark Results [WallFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WALLFLEX
WALLFLEX
78408742 3121616 Live/Registered
BOSTON SCIENTIFIC SCIMED, INC.
2004-04-27

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